MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ADVANTA V12 COVERED STENT; STENT, ILIAC

Model Number 85330

Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907)

Patient Problems Embolism/Embolus (4438); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

It was reported that the stent slipped off the balloon from the catheter leaving the stent hanging free in the aorta before inflation of the balloon.To get the stent out of the body they used the balloon distal to the stent to deliver it at the punitive side at right femoral artery.

Manufacturer Narrative

Based on the details provided the stent was dislodged off the balloon prior to deployment while attempting to reposition the stent in the renal artery.The product regarding this case was not returned for evaluation.Without the device in question or images from the case it is not possible to confirm the complaint.The details do indicate that the stent had to be repositioned during the case.It is possible that the stent was pulled back towards the sheath during this repositioning and the crimped stent made contact with the distal end of the introducer sheath pushing the stent off the balloon.If this occurred it is possible to push the crimped stent off the balloon with the sheath if too much force is applied.A review of the device history records going back to the sub assembly level where the balloon is formed shows that there were no non-conformances noted and the product met all quality and performance requirements.Based on the details of the complaint and investigation results the complaint cannot be confirmed.There is no evidence to conclude that the advanta v12 was at fault or manufactured with a defect that would have lent itself to the stent coming off the balloon during the procedure.Based on the results of the investigation the most probable root cause is operational context, as it is possible the stent was pushed off the balloon by the introducer sheath, while attempting to reposition the device during the procedure.A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.H3 other text: device not available for return.

Event Description

N/a.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 11264005
• MDR Text Key: 229802730
• Report Number: 3011175548-2021-00119
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: EG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2022
• Device Model Number: 85330
• Device Catalogue Number: 85330
• Device Lot Number: 447187
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 7F SHEATH ON 0.035 GUIDE WIRE; 7F SHEATH ON 0.035 GUIDE WIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male